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Trial · Interventional

CompletedPhase 4Registry data

Endothelial Function in Prostate Cancer Patients on Degarelix vs. Luteinizing Hormone-Releasing Hormone Agonists

NCTNCT02475057 (opens ClinicalTrials.gov in a new tab)Other id0102-15-RMC
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
80 participants (actual)
Sponsor
Rabin Medical Center · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Israel

Start
Aug 2015
Primary completion
Jul 2018
Completion
Jun 2019
First posted
18 Jun 2015 (estimated)
Last update posted
12 Jun 2019
Conditions
Prostatic Neoplasms · Cardiovascular Diseases

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017201820192020
  1. Ph 4

    Endothelial Function in Prostate Cancer Patients on Degarelix vs. Luteinizing Hormone-Releasing Hormone Agonists

    NCT02475057

    Aug 2015 to Jun 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to test whether Degarelix is associated with less endothelial dysfunction (an intermediate in the development of cardiac disease) and cardiovascular biomarkers compared to LHRH agonists.

Interventions

  • Degarelix (LHRH antagonist)Drug
  • LHRH agonistDrug
  • EndoPAT2000Device

Arms2

  • Experimental

    Degarelix (LHRH antagonist)

    Degarelix (LHRH antagonist) EndoPAT2000

  • Active comparator

    LHRH agonist

    LHRH agonist at the discretion of the treating Urologist/Oncologist EndoPAT2000

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Reactive Hyperemia Index from baseline to twelve months

    Time frame · Baseline, and twelve months

    Registry description

    the Reactive Hyperemia Index is a measure of endothelial function. It will be measured using the EndoPAT2000

Secondary outcomes(4)

  1. Change in High sensitivity troponin (hsTn) value

    Time frame · Baseline, and after three, six and twelve months of treatment initiation

    Registry description

    High sensitivity troponin (hsTn) is a biomarker for acute myocardial injury

  2. Change in C-reactive protein value

    Time frame · Baseline, and after three, six and twelve months of treatment initiation

    Registry description

    C-reactive protein is a biomarker for inflammation

  3. Change in D-dimer value

    Time frame · Baseline, and after three, six and twelve months of treatment initiation

    Registry description

    D-dimer is a biomarker for coagulation system activation

  4. Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) value

    Time frame · Baseline, and after three, six and twelve months of treatment initiation

    Registry description

    N-terminal pro-brain natriuretic peptide (NT-proBNP) is a biomarker for myocardial strain

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedZengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2. PMID 34350976

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 90 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male patients with locally advanced or metastatic prostate cancer or high-risk prostate cancer. * Scheduled to start ADT for a period of at least one year. * Subject has a history of one or more of the following: 1. Myocardial infarction 2. Ischaemic or Haemorrhagic cerebrovascular conditions 3. Arterial embolic and thrombotic events, 4. Ischaemic heart disease 5. Prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures) 6. Peripheral vascular disease (e.g. significant stenosis (ABPI\<0.9), claudication, prior vascular surgery/intervention) * Life expectancy of over 12 months. * WHO performance status of 0-2 * Subject is able and has agreed to sign a consent form. Exclusion Criteria: * Prior use of ADT. However, prior use of anti-androgens such as Casodex, Chimax, Drogenil, and Cyprostat will be allowed. * Prior use of dutasteride/finasteride in past 6 months * Known allergic reaction to Degarelix. * Any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.

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